510(k) K060123

LEVELERT II FLUID LEVEL SENSOR by Smith & Nephew, Inc. — Product Code FLN

K060123 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "LEVELERT II FLUID LEVEL SENSOR". The FDA issued a decision of Substantially Equivalent on February 14, 2006. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2006
Date Received
January 18, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type